FIOR & GENTZ NEURO MATIC User manual

Patienteninformation
Patient Information
Druckdatum: 2018-08
Der Inhalt dieser Patienteninformation wird regelmäßig aktualisiert und ist beim Einsatz des Produktes unbedingt zu beachten.
Sie finden diese Patienteninformation auch im Download-Bereich unserer Website unter www.fior-gentz.de/downloads. Seite 2
Date printed: 2018-08
This patient information is regularly updated and should be strictly followed.
You can also find this patient information in the download section on our website at www.fior-gentz.com/downloads. Page 9
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Content Page
1. Declaration of Conformity 10
2. Warranty 10
3. Safety Instructions 10
3.1 Classification of the Safety Instructions 10
3.2 All Instructions for Your Safety 11
4. Application 12
5. Using the Orthosis 12
5.1 Basic Function in Auto Mode 12
5.2 Alternative Function in Lock Mode 13
5.3 Alternative Function in Free Mode 13
5.4 The Lever 13
5.5 The Proper Shoe 14
5.6 Gait Re-education 14
6. Cleaning the Orthosis 14
7. Maintenance of the Orthosis 14
8. Disposal of the Orthosis 14
9. Follow-up Appointments 16

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Dear Patient,
You have received from your orthotist an individually produced orthosis with the high quality FIOR &GENTZ
NEURO MATIC system knee joint.
1. Declaration of Conformity
We declare that our medical devices as well as our accessories for medical devices are in conformity with the
requirements of the Medical Devices Directive 93/42/EEC. Therefore, the FIOR &GENTZ products bear the CE marking.
2. Warranty
The warranty only applies if the product is used under the described conditions and for the intended purpose.
The warranty expires if the product is used differently, if it is combined with other components or materials or
if it is mounted according to a different production technique than the one recommended by the FIOR &GENTZ
Orthosis Configurator. A combination with products from other manufacturers requires a written consent by the
seller. The warranty and guarantee expire if the product is mounted several times. For further information, we
refer to our General Terms and Conditions of Business Transactions, Sales, Delivery and Payment.
3. Safety Instructions
In order that your orthosis works in the best way, you can handle it correctly and you can use it as long as possible,
please note all information provided in this patient information, especially the safety instructions indicated by
DANGER, WARNING, CAUTION and NOTICE that are listed and explained in the following paragraph. Ignoring
this information may lead to injuries and property damage.
3.1 Classification of the Safety Instructions
DANGER Important information about a possible dangerous situation which,
if not avoided, leads to death or irreversible injuries.
WARNING
Important information about a possible dangerous situation which,
if not avoided, leads to reversible injuries that need medical treatment.
CAUTION
Important information about a possible dangerous situation which,
if not avoided, leads to light injuries that do not need medical treatment.
NOTICE Important information about a possible situation which,
if not avoided, leads to damage of the product.
All serious incidents connected to the product shall be reported to the manufacturer or your orthotist.

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3.2 All Instructions for Your Safety
DANGER
Potential Trac Accident Due to Limited Driving Ability
Gather information about all issues concerning safety and security and potential dangers,
e.g. unintentional locking of the system joint, before driving a motor vehicle with orthosis.
WARNING
Risk of Falling Due to Loosely Attached Cover Plate
Do not secure screws for the system joint on your own. Consult your orthotist about the
maintenance intervals to be respected.
WARNING
Risk of Falling Due to Improper Handling
Have your orthotist inform you about the correct use of the system joint and potential dangers.
Avoid contact with moisture and water.
WARNING
Risk of Falling Due to Improper Shoe
Wear a shoe to which your orthosis is adjusted in order to avoid joint dysfunction.
WARNING
Risk of Falling Due to Orthosis Adjustments
If you notice any changes on the orthosis (e.g. loosely attached joint components or changed
spring forces), immediately contact your orthotist.
WARNING
Risk of Falling Due to Improper Cleaning
In order to avoid a failure of the lock function, clean the orthosis and the system joint as
described in this manual. Do not grease the system joint on your own. If necessary, consult
your orthotist.
WARNING
Risk of Falling Due to Walking Incorrectly with Orthosis
Consult your orthotist about the correct use of your orthosis and the particularities of the
system joint. If necessary, we recommend a physiotherapeutic gait re-education.

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4. Application
The NEURO MATIC system knee joint is exclusively for use for orthotic fittings of the lower extremity. It must
be handled by a professionally trained user.
Every mechanical joint influences the orthosis' function and thus also the function of your leg. All FIOR &GENTZ
system joints were developed for everyday life activities such as standing, walking and running but not for
extreme loads due to sports such as climbing and parachuting.
Depending on the type of orthotic fitting and your individual physical abilities, driving a motor vehicle safely
should be guaranteed. This is subject to national laws and checked by authorised medical bodies. It is recom-
mended to modify the motor vehicle to your special needs (e.g. automatic transmission) so that the driving
ability is given even without a functioning orthosis.
5. Using the Orthosis
5.1 Basic Function in Auto Mode
In Auto mode, the NEURO MATIC system knee joint is a joint that locks and unlocks auto-
matically in certain phases. The system joint is locked when you need stability during stance
phase and it is unlocked in swing phase or when sitting down (fig. 1-2).
Locking in Auto Mode
The foot lowers as soon as the heel is set on the ground. This triggers a system knee joint mechanism which, in
turn, is causing the toothed parts to mesh and the system knee joint to lock (fig. 3).
Unlocking in Auto Mode
The foot is lifted when one leg is set back. This and applying an extension moment triggers a system knee joint
mechanism which, in turn, is causing the toothed parts to loosen and the system knee joint to unlock (fig. 4).
fig. 1
fig. 3 fig. 4
fig. 2

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5.2 Alternative Function in Lock Mode
In Lock mode, the NEURO MATIC system knee joint is a locked joint to provide motion control. As it is permanently
mechanically locked, you must first unlock the system joint mechanically again if you want to flex your knee.
This mode is of advantage if you do not feel secure in using your orthosis in Auto mode yet.
5.3 Alternative Function in Free Mode
In Free mode, the NEURO MATIC system knee joint is a free moving joint to
provide motion control. You can use your orthosis as a free moving one. We
recommend to use this mode for activities such as driving a car or cycling.
5.4 The Lever
At the system joint, there is a lever for the switching pawl and the three
marked letters F, A and L.
F stands for Free mode, A stands for Auto mode and L stands for Lock
mode (fig. 5). You can use the lever to select the desired mode for your
orthosis. Proceed as described in the following table:
Selecting a Mode Explanation Figure
from Auto mode into Lock mode Take load o the extended orthosis, i.e. do not
exert any force on the orthosis. 6 and 7
from Lock mode into Auto mode Take load o the extended orthosis, i.e. do not
exert any force on the orthosis. 6 and 7
from Auto mode into Free mode
Apply an extension moment to unlock the orthosis.
You can sit down and manually press the knee
backwards to do so.
8
from Free mode into Auto mode There is nothing special to consider. without fig.
from Lock mode into Free mode
First, you have to take load o the orthosis in order
to select Auto mode. Then, you have to apply an
extension moment to unlock the orthosis in order
to select Free mode.
without fig.
fig. 5
F
A
L
lever
fig. 7fig. 6 fig. 8

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5.5 The Proper Shoe
The orthotist adjusts your orthosis when you try it on and do your first steps. Since you have to get used to your
new orthosis, the adjusted orthosis should be regularly checked in the first weeks and, if necessary, newly adapted
to your need for safety. The orthosis is adjusted to the pair of shoes with which you start walking with your
orthosis. If you want to wear other shoes, it must be ensured that the orthosis is also adjusted to these shoes.
5.6 Gait Re-education
We recommend making use of a physiotherapeutic gait re-education. In gait re-education, the following should
be specially trained:
-a sufficient step length, as this is decisive for the system knee joint working properly;
-walking upright, with the upper body slightly bent forward;
-to apply as little body weight as possible on orthopaedic devices such as canes, parallel bars or walkers,
otherwise the lock function is not triggered.
With gait re-education, you become more secure in using your orthosis, your gait pattern improves and you get
used to your orthosis quite soon. This is particularly important when a locked orthosis has been used before for
many years.
Be extremely careful when managing stairs, going on uneven surfaces or uphill/downhill. If you do not feel secure
in using your orthosis in Auto mode yet, we recommend selecting Lock mode (see paragraph 5.2). Regularly
report to your orthotist your experiences with the orthosis during the first weeks. This is the only way you can
get specific advice or help.
6. Cleaning the Orthosis
Clean the orthosis regularly. Make sure that you do not immerse the orthosis in water or other liquids since this
can damage the system components and therefore influence the joint function negatively.
Clean the orthosis with a damp cloth. Leave out the area around the system joint and clean it only superficially
with a dry cloth. Remove visible dust and lint from the mechanics by using tweezers. Check the orthosis in a
straight and flexed position.
7. Maintenance of the Orthosis
Experience shows that children and people with cognitive impairments are often not able to notice and pass on
information about changes on the orthosis and especially on the system joint. We would like to point out that
you as parents or care team have to check the orthosis or more specifically the system joint regularly for signs
of wear such as play in the system joint or unusual noises. In case of changes, immediately get in touch with
your orthotist, regardless of the next follow-up appointment.
Furthermore, we would like to point out that you must not carry out any maintenance or other adjustments to
your orthosis by yourself. This might cause injuries and damage the orthosis. If adjustments or repairs of the
orthosis become necessary, always contact your orthotist.
8. Disposal of the Orthosis
If you no longer need the orthosis, please return it to your orthotist. The product must not
be disposed of with the residual waste (fig.9).
fig. 9
The more physiological the gait characteristics become, the better the orthosis can support you.

PB3000-SK/1D-08/2018
9. Kontrolltermine/Follow-up Appointments
Bitte lassen Sie das Systemgelenk Ihrer Orthese alle 3 Monate von Ihrem Orthopädietechniker warten.
Bringen Sie diese Patienteninformation zu jeder Kontrolle mit und lassen Sie den nächsten Termin von Ihrem
Orthopädietechniker eintragen.
Ask your orthotist to check the system joint of your orthosis every 3 months.
Bring this patient information to each follow-up and let your orthotist enter the next appointment.
Abgabe am
Delivery on Durch Mitarbeiter Orthotist Datum/Unterschrift Date/Signature Nächster Kontrolltermin Next Follow-up
Ihre Orthopädie-Werkstatt (Stempel)
Orthotic Provider (Stamp)
Der Qualitätsstandard der Firma FIOR & GENTZ ist durch eine unabhängige Zertifizierungsgesellschaft nach den
internationalen Normen ISO 9001 und ISO 13485 geprüft und bescheinigt worden.
The quality standard of the FIOR & GENTZ company has been controlled and certified by an independent certification organisation
according to the international standards ISO 9001 and ISO 13485.
Gesellschaft für Entwicklung und Vertrieb
von orthopädietechnischen Systemen mbH
Dorette-von-Stern-Straße 5
21337 Lüneburg (Germany)
info@fior-gentz.de
www.fior-gentz.com
[phone]
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